Related Summaries

BIO praised a Florida Senate committee for passing a bill that would require pharmacists to notify physicians when a biosimilar drug was substituted for a brand-name biologic. S.B. 732 has a five-year sunset clause like the law signed in Virginia last month. "Biosimilars are not generics. Even slight changes to a biologic drug can change its properties entirely. Unlike conventional generic medicines, biosimilars are not the same as the drugs they seek to substitute," the BIO statement said.

Legislatures in at least 17 states are considering proposals to restrict the substitution of biosimilar drugs for brand-name biologics. Virginia recently passed such a law, and a bill under consideration in Oregon may be the most restrictive.

A Florida House subcommittee approved a bill that would require pharmacists to alert prescribing doctors when they substitute a biosimilar drug for a brand-name biologic drug and to keep records of biosimilar substitutions for four or more years. Opponents, including pharmacy benefit managers, pharmacists and some drugmakers, say the bill would stifle innovation, deny patients needed care and keep drug costs high.

A Colorado House committee passed a bill that would restrict pharmacists' ability to substitute less-expensive biologic drugs for those sold under brand names. Substitution would be allowed only if the FDA has deemed the biosimilar interchangeable with the brand-name drug for the specific indication and if the prescribing doctor allows the substitution.

Bills that would have restricted pharmacists' ability to substitute biosimilar drugs for brand-name therapies failed to advance out of committees in the Mississippi House and Senate. Proponents say that pharmacists should be allowed to substitute only a biosimilar FDA-approved as "interchangeable" with the brand-name biologic drug for the specific indication and that doctors' orders to dispense as written should override payer policies. Opponents say the federal Public Health Service Act allows automatic substitution and the Mississippi legislation and other bills like it are simply an effort to protect drugmaker profits.